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Trial registered on ANZCTR


Registration number
ACTRN12624000977572p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2024
Date registered
12/08/2024
Date last updated
12/08/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Virgin Coconut Cream on Radiation Dermatitis and Quality of Life among Radiotherapy Cancer Patients
Scientific title
The Effect of Virgin Coconut Cream on Radiation Dermatitis and Quality of Life among Radiotherapy Cancer Patients: A Double-Blind Randomized Control Trial
Secondary ID [1] 312389 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation Dermatitis 334194 0
Poor quality of life 334195 0
Condition category
Condition code
Cancer 330853 330853 0 0
Head and neck
Skin 331100 331100 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention product: Virgin coconut cream
Dose: 15 g 2.5 Fingertips unit twice/day
Route/ mode: Topical
Duration: Until developing grade 3 radiation dermatitis or until complete radiotherapy treatment (6 weeks to 7 weeks)
Strategy to assess adherence to the interventions: Review participants medical record and weekly review
Intervention code [1] 328889 0
Prevention
Intervention code [2] 329087 0
Treatment: Drugs
Comparator / control treatment
Intervention product: Hydrocortisone Cream 1%
Dose: 15 g 2.5 Fingertips unit twice/day
Route/ mode: Topical
Duration: Until developing grade 3 radiation dermatitis or until complete radiotherapy treatment (6 weeks to 7 weeks)
Strategy to assess adherence to the interventions: Review participants medical record and weekly review
Control group
Active

Outcomes
Primary outcome [1] 338619 0
Delaying grade 3 radiation dermatitis
Timepoint [1] 338619 0
Baseline (Before starting radiotherapy), 5 fraction of radiotherapy, 10 fraction `of radiotherapy, 15 fraction of radiotherapy (primary timepoint), 20 fraction of radiotherapy, 25 fraction of radiotherapy, 30 fraction of radiotherapy, 35 fraction of radiotherapy
Primary outcome [2] 338865 0
Skin changes
Timepoint [2] 338865 0
Baseline (Before starting radiotherapy), 5 doses of radiotherapy, 10 doses of radiotherapy, 15 doses of radiotherapy, 20 doses of radiotherapy, 25 doses of radiotherapy, 30 doses of radiotherapy, 35 dose of radiotherapy
Secondary outcome [1] 436673 0
Quality of Life
Timepoint [1] 436673 0
Baseline (Before starting radiotherapy), 5 doses of radiotherapy, 10 doses of radiotherapy, 15 doses of radiotherapy, 20 doses of radiotherapy, 25 doses of radiotherapy, 30 doses of radiotherapy, 35 dose of radiotherapy (secondary timepoint)

Eligibility
Key inclusion criteria
Confirm diagnosis head and neck cancer, adjuvant and radical treatment, minimum dose radiation 55 Gy, No metastasis
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Language barrier, foreigner patient, have skin problem, allergic to virgin coconut and hydrocortisone product, uncontrolled diabetics

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization and allocation concealment will be conducted after receiving informed consent. The participant will be randomized by using block randomization (1:1). The researcher will identify from the radiographer the number of participants that will start radiotherapy treatment for each week for one month within the data collection period. Envelopes will be prepared according to the ratio for randomization and number of participants; Group A and Group B. Group labels will be placed into an envelope, along with a questionnaire and informed consent. The envelope will be distributed to the participants based on first come and first serve basis during recruitment.
Researchers will conduct this research along with medical officers and oncologist nurses to ensure participants will receive adequate monitoring. Product A will be provided by a local company and product B will be prepared by pharmacist Hospital Kuala Lumpur. Both products will be labelled by the pharmacist in charge which is provided by the researcher. To ensure double blind, intervention and control will be prepared in the same container and texture in order to prevent bias to the patient and researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization of choosing a random envelope that will be given by the investigator by using a 1:1 ratio. Inside the envelope, will receive a card with the alphabet A and B. Participants will be grouped by using those cards.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A total number of samples is 60 participants, which is divided into 30 control groups and 30 for intervention. This sample size is calculated by using RCT sample size formulae (proportion)
For weekly data, Repeated measure ANOVA will be used (Objective 2&4)
Descriptive (Frequency, Percentage) (Objective 1,3 & 4)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26392 0
Malaysia
State/province [1] 26392 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 316797 0
Self funded/Unfunded
Name [1] 316797 0
Country [1] 316797 0
Primary sponsor type
Individual
Name
Nur Hidayah Awaludin - Universiti Teknologi Mara
Address
Country
Malaysia
Secondary sponsor category [1] 319019 0
Other
Name [1] 319019 0
University Teknologi MARA, UiTM Puncak Alam Campus
Address [1] 319019 0
Country [1] 319019 0
Malaysia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315566 0
National Medical Research Registry (NMRR)
Ethics committee address [1] 315566 0
03-3362 8205/8079/8898
Ethics committee country [1] 315566 0
Malaysia
Date submitted for ethics approval [1] 315566 0
20/06/2024
Approval date [1] 315566 0
Ethics approval number [1] 315566 0
Ethics committee name [2] 315567 0
Universiti Teknologi MARA, Faculty Research Ethics Committee
Ethics committee address [2] 315567 0
Faculty Health Science, University Teknologi MARA (UiTM) Puncak Alam Bandar Puncak Alam Campus, 42300 Puncak Alam, Selangor, Malaysia
Ethics committee country [2] 315567 0
Malaysia
Date submitted for ethics approval [2] 315567 0
14/06/2024
Approval date [2] 315567 0
Ethics approval number [2] 315567 0
Ethics committee name [3] 315827 0
University Malaya Medical Centre, Medical Research Ethics Committee (MREC)
Ethics committee address [3] 315827 0
University Malaya Medical Centre (UMMC), Lembah Pantai, 59100, Kuala Lumpur, MALAYSIA
Ethics committee country [3] 315827 0
Malaysia
Date submitted for ethics approval [3] 315827 0
29/07/2024
Approval date [3] 315827 0
Ethics approval number [3] 315827 0

Summary
Brief summary
This study will assess the effectiveness of an intervention on patient outcomes of the effect of virgin coconut cream on radiation dermatitis. Participants' information will remain confidential, and their involvement is voluntary. All data will be anonymized. The hypothesis is that the intervention will improve health outcomes.
Trial website
Trial related presentations / publications
Public notes
The research proposal and study materials will be compiled and submitted for approval by the Research Ethics Community (REC) UiTM and NMRR. The respondents' personal information will be confidential for samples, and they voluntarily participate in the study. The study population will be informed of the objectives and processes, and the collected data will be anonymized and kept confidential. Informed consent will be obtained through the Participant Inform Sheet (PIS), and participants may voluntarily participate or withdraw from the study at any time.

Contacts
Principal investigator
Name 135098 0
Mrs NUR HIDAYAH AWALUDIN
Address 135098 0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Country 135098 0
Malaysia
Phone 135098 0
+60173883864
Fax 135098 0
Email 135098 0
[email protected]
Contact person for public queries
Name 135099 0
NUR HIDAYAH AWALUDIN
Address 135099 0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Country 135099 0
Malaysia
Phone 135099 0
+60173883864
Fax 135099 0
Email 135099 0
[email protected]
Contact person for scientific queries
Name 135100 0
NUR HIDAYAH AWALUDIN
Address 135100 0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Country 135100 0
Malaysia
Phone 135100 0
+60173883864
Fax 135100 0
Email 135100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.